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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) VOLIFT WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) VOLIFT WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 94201JR
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Cyst(s) (1800); Unspecified Infection (1930); Skin Irritation (2076)
Event Date 04/03/2018
Event Type  Injury  
Manufacturer Narrative
The events of "infection", "cyst", "hard", "edema", "erythema", "right side slightly hanging" and "soreness" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events. A review of the device history record has been initiated. If any new, changed or corrected information is noted, a supplemental medwatch will be submitted. Device labeling addresses the reported event(s) as follows: precautions for use: as a matter of general principle, injection of a medical device is associated with a risk of infection. Standard precautions associated with injectable materials shall be followed. Undesirable effects: the patients must be informed that there are potential side effects associated with implantation of this product, which may occur immediately or may be delayed. These include, but are not limited to: inflammatory reactions (redness, oedema, erythema, etc. ) which may be associated with itching and/or pain on pressure and/or paresthesia, occurring after the injection. These reactions may last for a week. In particular, it has to be noticed that injection in the mucous membrane may cause more oedema and bruising due to the specific physiology of theses tissues. Besides, a preventive anti-inflammatory treatment by a medical practitioner can be recommended. Induration or nodules at the injection site. Warnings: do not re-use. Sterility of this device cannot be guaranteed if the device is re-used.
 
Event Description
Healthcare professional (hcp) reported patient was injected with 1 ml of juvéderm® volift¿ with lidocaine in the nasolabial folds. Injection sites were treated with alcohol (85%) before injection. The next day, patient presented with "a 2x3 cm hard, taught cyst, with surrounding edema, causing the corner of the mouth to droop" in the right nlf. Hcp also observed erythema, some soreness, and indicated "right side slightly hanging". Hcp determined "this was not a drainable infection and [prescribed] dicillin tablets, 1 gr x 4 and benadryl 8 mg x 2". 2 days after onset "soreness and erythema had decreased, while the cyst more well-defined and taught, but still assessed as undrainable. " hcp administered "100 iu hyalase". Hcp later reviewed patient and noted "today the cyst is 1 x 2 cm and less taught and less sore, there is some slightly increasing declive edema". Hcp instructed patient to "continue 1 dicillin x 3 for 10 days. " symptoms resolved 6 days after onset.
 
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Brand NameVOLIFT WITH LIDOCAINE
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
ALLERGAN (PRINGY)
route de promery
zone artisanale de pre-mairy
pringy 74370
FR 74370
Manufacturer (Section G)
ALLERGAN (PRINGY)
route de promery
zone artisanale de pre-mairy
pringy 74370
FR 74370
Manufacturer Contact
suzanne wojcik
301 w howard lane
suite 100
austin, TX 78753
7372473605
MDR Report Key7545438
MDR Text Key109291992
Report Number3005113652-2018-00713
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
P110033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 05/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2019
Device Catalogue Number94201JR
Device Lot NumberV17LA70130
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/08/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 05/25/2018 Patient Sequence Number: 1
Treatment
ALCOHOL (85%) AND "AFSPRITNING" BEFORE INJECTION
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